Seminars in Spine Surgery RSS feed: Articles in Press. Seminars in Spine Surgery is a continuing source of current, clinical information for practicing surgeons. Under the direction of a specially selected guest editor, each issue addresses a single topic in the management and care of patients. Topics covered in each issue include basic anatomy, pathophysiology, clinical presentation, management options and follow-up of the condition under consideration. The journal also features "Spinescope," a special section providing summaries of articles from other journals that are of relevance to the understanding of ongoing research related to the treatment of spinal disorders. http://www.semspinesurg.com//inpress?rss=yesElsevier Inc.en © 2011 Elsevier Inc. All rights reserved. Seminars in Spine Surgery1040-73832012-01-30 © 2011 Elsevier Inc. All rights reserved. healthpermissions@elsevier.comhttp://www.semspinesurg.com/article/PIIS1040738311001043/abstract?rss=yes A brief review of the conflicting desires of a medical profession's desire to be relieved of the burden of malpractice litigation in the context of the constitutional framework of the American legal systems has been conducted. The limits of restricting the rights of the citizen are addressed. The aim of this review is to provide a primer on the realities relating to the constitutional rights of the American citizen and the constructive purpose that litigation is believed to provide society. A review of available case law and learned treaties was undertaken to provide an insight into the workings of the legal system pertaining to issues of most interest to the spine community. The current legal system walks the fine line between protecting the public and their constitutional rights and ensuring that the delivery of medical care is not unduly impacted. It is the author's opinion that each specialty can positively affect the decisions of the courts by providing firm guidance as to what is and is not the “standard of care,” thus preventing fallacious expert testimony from reaching the jury. The Legal Ramifications of Spinal Care Medical Malpractice and Its Implications for Spinal Surgery - Corrected ProofJames Ghadially10.1053/j.semss.2011.11.020Seminars in Spine Surgery (2012)2012-01-30Seminars in Spine Surgery2012-01-30http://www.semspinesurg.com/article/PIIS1040738311001018/abstract?rss=yes Evidence-based approaches to the treatment of spinal pathology are needed as the field evolves. Patient-reported outcomes have become the standard by which therapeutic success is defined. There are 4 types of commonly used outcome measures: generic, disease specific, pain scales, and health utilities. Using this framework to evaluate outcomes allows for cost-effectiveness studies to be done and define the value of spinal care to society. Spinal Care: What Measurements Should be Used to Define Value to Society? - Corrected ProofKathryn J. McCarthy, Leah Y. Carreon, Steven D. Glassman10.1053/j.semss.2011.11.017Seminars in Spine Surgery (2012)2012-01-24Seminars in Spine Surgery2012-01-24http://www.semspinesurg.com/article/PIIS1040738311000852/abstract?rss=yes Anterior cervical diskectomy and fusion is one of the most commonly performed cervical spine procedures with historically excellent results. In an effort to preserve segmental motion and prevent adjacent segment degeneration, cervical total disk replacement was developed. Although the short-term data show comparable results, its superiority to ACDF remains controversial. This manuscript will highlight the literature that has supported ACDF as a treatment option for single level cervical pathology. In addition, we will review adjacent segment disease, its natural history, and what to expect as we begin to see the long-term results from total disk replacement. The Argument for Anterior Cervical Diskectomy and Fusion Over Total Disk Replacement - Corrected ProofJeremy S. Smith, Melvin D. Helgeson, Todd J. Albert10.1053/j.semss.2011.11.002Seminars in Spine Surgery (2012)2012-01-16Seminars in Spine Surgery2012-01-16http://www.semspinesurg.com/article/PIIS1040738311000955/abstract?rss=yes Knowledge regarding the in vivo performance and periprosthetic tissue response of cervical and lumbar total disc replacements (TDRs) continues to expand. This review addresses the following 4 main questions: (1) What are the latest lessons learned from using polyethylene in large joints and how are they relevant to current TDRs? (2) What are the latest lessons learned regarding adverse local tissue reactions from metal-on-metal cobalt-chrome bearings in large joints and how are they relevant to current TDRs? (3) What advancements have been made in understanding the in vivo performance of alternative biomaterials, such as stainless steel and polycarbonate urethane, for TDRs in the past 5 years? (4) How has retrieval analysis of all these various artificial disc bearing technologies advanced the state-of-the-art in preclinical testing of TDRs? The study of explanted artificial discs and their associated tissues can help inform bearing selection as well as the design of future generations of disc arthroplasty. Analyzing retrieved artificial discs is also essential for validating preclinical test methods. The Latest Lessons Learned from Retrieval Analyses of Ultra-High Molecular Weight Polyethylene, Metal-on-Metal, and Alternative Bearing Total Disc Replacements - Corrected ProofSteven M. Kurtz, Jeffrey M. Toth, Ryan Siskey, Lauren Ciccarelli, Daniel MacDonald, Jorge Isaza, Todd Lanman, Ilona Punt, Marla Steinbeck, Jan Goffin, André van Ooij10.1053/j.semss.2011.11.011Seminars in Spine Surgery (2012)2012-01-16Seminars in Spine Surgery2012-01-16http://www.semspinesurg.com/article/PIIS1040738311000967/abstract?rss=yes The growing list of total disc replacements attempts to give options and variability to surgeons while treating degenerative disc disease. However, despite surgeon and patient interest, their path to market has been hindered. Although several variables affect device commercialization, regulatory hurdles have routinely been the focus. In response to device designs outpacing clinically relevant means to assess risks, Food and Drug Administration has resorted to prospective randomized clinical data to evaluate these devices. With road maps essentially laid out by previous approvals, the ever-changing priorities at the Food and Drug Administration continue to make the pathway for getting a new total disc replacement to market bumpier and bumpier. Regulatory Challenges in Getting Total Disc Replacements Onto the Market in an Era of Increased Food and Drug Administration Scrutiny - Corrected ProofGlenn Stiegman, Kevin B. McGowan10.1053/j.semss.2011.11.012Seminars in Spine Surgery (2012)2012-01-16Seminars in Spine Surgery2012-01-16http://www.semspinesurg.com/article/PIIS1040738311000864/abstract?rss=yes ProDisc-C cervical disc arthroplasty is a prosthesis that has a cobalt chrome/polyethylene bearing surface and is semi-constrained. It was developed based on the design of the ProDisc-L lumbar disc arthroplasty. ProDisc-C cervical disc arthroplasty has undergone the FDA investigation device exemption trial. The results from this trial at two years as well as a four year clinical study of the same patients as well as continued access patients will be reported. Further studies in the literature concerning heterotopic ossification as well as biomechanical and radiographic evaluations of ProDisc-C are reported. ProDisc-C Cervical Disk Arthroplasty - Corrected ProofBruce V. Darden10.1053/j.semss.2011.11.003Seminars in Spine Surgery (2012)2012-01-05Seminars in Spine Surgery2012-01-05http://www.semspinesurg.com/article/PIIS1040738311000931/abstract?rss=yes Nucleus replacement devices have been developed with the goal of treating moderate forms of degenerative disk disease, trying to fill the gap between discectomy and fusion. This is a retrospective analysis of a nonrandomized, single-center clinical series of 125 patients, presenting with moderate forms of degenerative disk disease and treated with nuclear replacement devices. Eighty patients were treated with prosthetic disk nucleus (Ray Medica) disk prosthesis, 26 patients with percutaneous nucleus replacement (TranS1), and 19 patients using the NUBAC (Pioneer) devices. The surgical techniques for each device were performed following the prosthesis indications. Patients were followed up to 9 years postoperatively, and their complications were recorded. After 9 years' follow-up, the overall retrieval incidence was 48.8% (61/125). Of these, 15 (57.7%) had PNR failures, 8 (42.1%) experienced NUBAC retrievals, and 38 (47.5%) had prosthetic disk nucleus flaws. The failures included significant loss of disk height at the operated level, displacement, silicon inside the spinal canal, and migration. All patients underwent fusion as a retrieval surgery. The retrieval rate in our series was very high. It shows that endplate reactions occur in a high percentage of patients over time, resulting in subsidence and mechanical back pain. Device expulsion was another cause of pain requiring revision surgery. Lessons Learned After 9 Years' Clinical Experience with 3 Different Nucleus Replacement Devices - Corrected ProofLuiz Pimenta, Luis Marchi, Etevaldo Coutinho, Leonardo Oliveira10.1053/j.semss.2011.11.009Seminars in Spine Surgery (2012)2012-01-05Seminars in Spine Surgery2012-01-05http://www.semspinesurg.com/article/PIIS104073831100092X/abstract?rss=yes Advancements in lumbar total disk replacement (TDR) and motion preserving technology have become more prevalent. With the clinical application of these devices, complications and failures will need to be addressed. These complications have been correlated with patient and surgeon related factors. Successful management is dependant on identifying the mode of failure and surgeon awareness of approach related complications. Adhering to patient selection criteria and avoiding technical errors can minimize device failure. When revision surgery is indicated, careful preoperative planning is mandated in order to identify the underlying pathology and obtain successful revision goals. Reoperations and Complications of Failed Lumbar Total Disk Replacement - Corrected ProofPaul C. McAfee, Behnam Salari, Sameer Saiedy10.1053/j.semss.2011.11.008Seminars in Spine Surgery (2012)2012-01-03Seminars in Spine Surgery2012-01-03ORIGINAL ARTICLEhttp://www.semspinesurg.com/article/PIIS1040738311000943/abstract?rss=yes Cervical and lumbar arthroplasty is being increasingly used over the past decade for the management of degenerative spinal disease with multiple varied devices available worldwide. As more experience is obtained with the devices currently available, the need for postoperative imaging has heightened. Plain x-rays are still useful for the assessment of device positioning, determination of range of motion, and to rule out potential device migration. Computed tomography scanning can be combined with this, but incorporation of newer devices into bony endplates is difficult to visualize. In cases where neural structures need to be assessed at operated or adjacent levels, magnetic resonance (MR) scanning is suitable in most titanium-based or nonmetallic devices but produces significant artifact in cobalt-chromium alloy-based devices. In this latter group, computed tomography myelography, which is more invasive than MR scanning, will need to be used. In time, it would be envisioned that nonmetallic devices made of plastics should allow for acceptable postoperative MR imaging. As our experience with the devices and their imaging increases, these recommendations may change; however, material properties play a greater role in the decision making of type of modality used for postoperative imaging in scenarios where interbody fusion is performed. Postoperative Imaging of Spinal Disk Arthroplasty Devices - Corrected ProofLali H. Sekhon10.1053/j.semss.2011.11.010Seminars in Spine Surgery (2012)2012-01-03Seminars in Spine Surgery2012-01-03http://www.semspinesurg.com/article/PIIS1040738311000980/abstract?rss=yes Defining value in spine surgery increasingly considers the patient's perspective, a task that requires quantifying outcomes using validated, patient-derived outcome instruments. Both general and disease-specific instruments have been used to measure outcomes after spinal surgery. Some outcomes instruments can be used to derive a utility score, a metric that grades patient health along a continuous spectrum from 0 to 1. The change in utility score after a procedure and the procedure cost are used to determine the cost per change in utility, a measurement that forms the basis of cost-effectiveness analysis and can be compared between procedures. Defining the Value of Spine Care to Society - Corrected ProofChristopher K. Kepler, Jeffrey A. Rihn, Alexander R. Vaccaro, Todd J. Albert10.1053/j.semss.2011.11.014Seminars in Spine Surgery (2012)2012-01-03Seminars in Spine Surgery2012-01-03http://www.semspinesurg.com/article/PIIS104073831100102X/abstract?rss=yes This article provides a general understanding of the fundamental differences between the Canadian and United States health care systems and how they may relate to spine care. Issues regarding sustainability of either system are beyond the scope of this article. The Canadian perspective is presented in this article. These 2 systems are fundamentally different regarding universality and accessibility of health care coverage and delivery. Comparative studies for a variety of health states, including spinal disorders, do not show significant differences in outcomes between countries for those who are insured. Consequently, the pro's and con's of both systems are variable depending on the perspective taken. Spinal Care in a Single-Payer System: The Canadian Example - Corrected ProofRaja Rampersaud, Kevin Macwan, Nizar N. Mahomed10.1053/j.semss.2011.11.018Seminars in Spine Surgery (2012)2012-01-03Seminars in Spine Surgery2012-01-03http://www.semspinesurg.com/article/PIIS1040738311000876/abstract?rss=yes Cervical arthroplasty was developed and is used to preserve segmental motion of the cervical spine for selected patients who require cervical diskectomy. There are now 3 cervical arthroplasty devices available for use in the United States. The data from the PRESTIGE ST US Food and Drug Administration Investigational Device Exemption trial and the relevant literature published on cervical arthroplasty devices were reviewed. The history of development, current clinical outcomes reports, and adverse events reports are summarized. Cervical arthroplasty is a safe and effective option for patients with single-level cervical disk disease with radiculopathy, who have normal facets. The appropriate inclusion and exclusion criteria for cervical arthroplasty from the US Food and Drug Administration trials must not be overlooked. Appropriate surgical technique will help optimize patient outcomes. PRESTIGE Cervical Arthroplasty: Past, Present, and Future - Corrected ProofJau-Ching Wu, Scott A. Meyer, Gurpreet Gandhoke, Praveen V. Mummaneni10.1053/j.semss.2011.11.004Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30http://www.semspinesurg.com/article/PIIS104073831100089X/abstract?rss=yes A review of the literature was performed to study the complications of cervical disk arthroplasty. The following early postoperative complications will be discussed in this article: persistent neurologic symptoms and neurologic complications, malpositioning of the prosthesis, and early mechanical failure. The following intermediate and long-term follow-up complications will be discussed: development of new neurologic symptoms and deficits, device-related complications (subsidence and wear), and heterotopic ossification. Cervical disk arthroplasty has proven to be safe and effective as an alternative to anterior cervical discectomy and fusion in many patients. Clinical results are good, and the complication rate is low. However, the development of heterotopic ossification and wear with vertebral body osteolysis has to be monitored carefully in the longer term. Unanticipated Outcomes After Cervical Disk Arthroplasty - Corrected ProofJohannes van Loon, Jan Goffin10.1053/j.semss.2011.11.005Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30http://www.semspinesurg.com/article/PIIS1040738311000906/abstract?rss=yes Lumbar total disk replacement (TDR) has been used in Europe for many years and since 2000 in the United States with the initiation of the Food and Drug Administration investigational device exemption trials. Patients enrolled in those prospective, randomized, controlled trials have now reached 5-year follow-up, the results of which are reported here for the ProDisc-L device. The follow-up rate at 5 years was 81.8% of the 236 patients randomized to either TDR or combined anterior/posterior instrumented fusion. In general, the results were stable from the 2- to 5-year follow-up periods. Both groups remained significantly improved from baseline, with noninferiority of the TDR compared with fusion being maintained. At 5-year follow-up, the range of motion of the levels treated with TDR was 7.7°. The study found that TDR and fusion are both viable treatments for chronic painful degenerative disk disease, with clinical improvements being maintained throughout the 5-year follow-up. Five-Year Results of the ProDisc-L Multicenter, Prospective, Randomized, Controlled Trial Comparing ProDisc-L With Circumferential Spinal Fusion for Single-Level Disabling Degenerative Disk Disease - Corrected ProofJack E. Zigler10.1053/j.semss.2011.11.006Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30ORIGINAL ARTICLEhttp://www.semspinesurg.com/article/PIIS1040738311000918/abstract?rss=yes Lumbar total disk replacement (TDR) has been used for the treatment of painful disk degeneration since the 1980s. Not until the Food and Drug Administration (FDA) regulated trials in the United States initiated in 2000 had there been formal prospective randomized trials evaluating the results of this technology compared with fusion, the traditional surgical treatment for disk degeneration. The purpose of this article was to provide a commentary on the results of the 5-year follow-up of CHARITÉ artificial disk (DePuy Spine, Raynham, MA) published by Guyer et al (Spine J 9:374-386, 2009) and to comment on this work in the context of other TDR literature. In the study, results of TDR using the CHARITÉ artificial disk, were compared with those of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disk disease from L4 to S1. The results of the 5-year, prospective, randomized multicenter study were consistent with the 2-year outcomes. The TDR group had improved functional outcomes based on visual analog pain scales, Oswestry Disability Index, and the SF-36 Physical component scores. CHARITÉ patients reached a greater rate of part- and full-time employment and a statistically lower rate of long-term disability compared with ALIF patients. Radiographically, the range of motion at the index and adjacent levels was maintained. The incidence of adjacent level degeneration was lower for TDR than in the fusion group. The results of this study indicate that TDR with the CHARITE produced results similar or superior to ALIF at 5-year follow-up. Outcomes of CHARITE Lumbar Artificial Disk versus Fusion: 5-Year Data - Corrected ProofRichard D. Guyer, Issada Thongtrangan, Donna D. Ohnmeiss10.1053/j.semss.2011.11.007Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30ORIGINAL ARTICLEhttp://www.semspinesurg.com/article/PIIS1040738311000979/abstract?rss=yes Challenges abound in our quest to define the “Social and Legal Ramifications of Spine Care.” These challenges exist not only in regards the present-day practice of spinal surgery but particularly with regard to delineating the “value” of spinal treatments to patients and society as a whole as healthcare reform is implemented in the United States. The principles of comparative effectiveness research (CER) have been adopted as parameters for measuring “value” in healthcare reform legislation. The CER approach uses economic analyses such as cost-effectiveness to deduce whether a particular intervention will be reimbursed. The conclusion of a cost-effectiveness analysis will be generally expressed as a cost (in $, €, £, etc) per patient gain in quality-adjusted life year (QALY). The National Institute for Health and Clinical Excellence in the United Kingdom has set a threshold of £30,000 (approximately 50,000 US dollars) per QALY gained as a ceiling for recommending a procedure be reimbursed under the UK National Health Service. No definite criteria have been set in the United States. Defining the value of spine care to society has a number of unresolved issues. These include who should define value (patients, physicians, government), how should we measure value (CER, clinical outcomes, direct cost only vs including indirect costs), and how much is society willing to pay for spine care ($50,000 per QALY as in the United Kingdom or should it be more in the United States). We will define many of these issues in the challenges article and leave subsequent authors in this issue to expound the details so that readers have a greater understanding of the challenges faced by us all in terms of defining the societal value of spine care. The final challenge, of course, is applying the value principles in a practice environment where many clinical decisions are influenced by legal ramifications. Important information for practitioners will be imparted in the final article of this issue. Social and Legal Ramifications of Spine Care: The Challenges - Corrected ProofDavid A. Wong, Katherine E. Wong10.1053/j.semss.2011.11.013Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30http://www.semspinesurg.com/article/PIIS1040738311000992/abstract?rss=yes Ideally, each patient should be provided with accurate information on outcome and cost and select care based on the best value and personal care preferences. Unfortunately, useful information on outcome is often absent or equivocal, and information on cost is obscured by the design of our health care system. Numerous efforts are underway to better empower patients in decision-making and support patient-centered research. Comparative effectiveness studies and patient registries will generate new information and may help to define value. Techniques for measurement of cost will need to be refined and more commonly used. While these efforts are progressing, medical societies, the government, and insurers have developed standardized methods to collect and analyze the current literature and make recommendations for care they believe valuable and appropriate. Clinical care guidelines, health technology assessments, meta-analysis, and appropriateness criteria are some of the structured methods for assessing the current evidence. These clinical care recommendations are useful but are incomplete and inadequate in defining value because of the absence of information on cost and the limited information on outcomes. Who Should Define Value in Spine Care? - Corrected ProofCharles Mick10.1053/j.semss.2011.11.015Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30http://www.semspinesurg.com/article/PIIS1040738311001006/abstract?rss=yesIt is an honor to be the Guest Editor for this issue of Seminars in Spine Surgery with the theme of “Social and Legal Ramifications of Spine Care.” We have assembled a stellar group of authors with specific topic expertise to write papers outlining some of the key issues in this subject area.Introduction - Corrected ProofDavid A. Wong10.1053/j.semss.2011.11.016Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30http://www.semspinesurg.com/article/PIIS1040738311001031/abstract?rss=yes In this era of constrained resources, spine care professionals are challenged to provide value and justification of resource allocation. For surgeons, this requires demonstration of clinical superiority that is both significant and durable compared with nonsurgical management and/or with other forms of surgical treatment. Value concepts such as the cost per quality-adjusted life year allow for more objective comparisons of treatment both for the same condition and for different conditions across a variety of disciplines. It thus becomes imperative that these concepts are learned and used in the design of future studies in the treatment of spinal disorders. Defining Appropriate Spine Care for the Patient as well as Society - Corrected ProofDavid W. Polly, Charles Gerald T. Ledonio, Jonathan N. Sembrano, Robert A. Morgan10.1053/j.semss.2011.11.019Seminars in Spine Surgery (2011)2011-12-30Seminars in Spine Surgery2011-12-30